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‘‘National Medical Device Registry21 ‘‘(g)(1) The Secretary shall establish a national med22 ical device registry (in this subsection referred to as the23 ‘registry’) to facilitate analysis of postmarket safety and24 outcomes data on each device that—25 ‘‘(A) is or has been used in or on a patient; and‘‘(B) is—2 ‘‘(i) a class III device; or3 ‘‘(ii) a class II device that is implantable,

A class III device and a class II device means: (i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is—(I) a class III device;(II) a class II device that is permanently implantable, is life supporting, or is life sustaining; or(III) a type of device which the Secretary has, by notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device, indicated should be subject to such part 803 in order to protect the public health; )

‘‘(iii) other postmarket device surveillance10 activities of the Secretary authorized by this11 chapter; and

‘‘(4) Not later than 36 months after the date of the22 enactment of this subsection, the Secretary shall promul23gate regulations for establishment and operation of the24 registry under paragraph (1). Such regulations—

‘‘(5) To carry out this subsection, there are author13ized to be appropriated such sums as may be necessary14 for fiscal years 2010 and 2011.’’.15 (2) EFFECTIVE DATE.—The Secretary of16 Health and Human Services shall establish and17 begin implementation of the registry under section18 519(g) of the Federal Food, Drug, and Cosmetic19 Act, as added by paragraph (1), by not later than20 the date that is 36 months after the date of the en21 actment of this Act, without regard to whether or22 not final regulations to establish and operate the23 registry have been promulgated by such date.